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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name audiometer
510(k) Number K090406
Device Name EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
Applicant
INTERACOUSTICS AS
DREJERVAENGET 8
ASSENS,  DK DK-5610
Applicant Contact HANNE NIELSEN
Correspondent
INTERACOUSTICS AS
DREJERVAENGET 8
ASSENS,  DK DK-5610
Correspondent Contact HANNE NIELSEN
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received02/17/2009
Decision Date 07/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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